Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 17, 2014
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Becton Dickinson & Co. recalled The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic… - a moderate-severity action.
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic… was recalled by Becton Dickinson & Co. in September 17, 2014. Reason: The performance of the assay no longer conforms to this statement in the Analytical Specificity section of th…. Check the official notice for the remedy. Verify recall #Z-2618-2014 with the FDA Devices before acting.
The recall
Becton Dickinson & Co. issued this moderate-severity FDA Devices recall-The performance of the assay no longer conforms to this statement in the Analytical Specificity section of th….
- Moderate
- severity level
- Class II
- classification
- September 17, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2618-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2618-2014) was formally reported on September 17, 2014, with the manufacturer initiating the action on July 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Becton Dickinson & Co. is listed as the recalling firm, operating out of Sparks, MD. Federal records list the affected scope as 585,048 tests.
The documented reason for this recall is: The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations … Distribution data in the federal record shows the product reached: US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
585,048 tests
Related Recalls
6
3 from same agency
Product description
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
Reason for recall
The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2618-2014 |
| Date reported | September 17, 2014 |
| Date initiated | July 23, 2014 |
| Recalling firm | Becton Dickinson & Co. |
| Firm location | Sparks, MD |
| Affected scope | 585,048 tests |
| Distribution | US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2618-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.. Recalled by Becton Dickinson & Co.. Units affected: 585,048 tests.
Why was this product recalled? ▼
The performance of the assay no longer conforms to this statement in the Analytical Specificity section of the Package Insert: One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAX MRSA Assay. One of the samples tested with each of the CAP surveys MRS5-A 2014 and MRS5-B 2014 yielded false positive results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 17, 2014. Severity: Moderate. Recall number: Z-2618-2014.
Where was the recalled product distributed? ▼
Distribution: US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2618-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 17, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.